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- BGE-102, a potent, structurally novel, orally available, brain-penetrant small molecule NLRP3 inhibitor developed from a hit identified via HitGen’s DEL technology platform, has advanced into a Phase 2 proof-of-concept trial for cardiovascular risk reduction.
- The QUELL-CV trial is designed to inform optimal dose selection in Phase 3 and BGE-102’s path forward in cardiovascular disease. Topline data are anticipated in the second half of 2026.
CHENGDU, China, July 14, 2026 /PRNewswire/ — Shanghai Stock Exchange listed company HitGen Inc. ("HitGen", SSE: 688222.SH), congratulates its partner BioAge Labs, Inc. ("BioAge"), a clinical-stage biopharmaceutical company developing therapeutic product candidates for cardiometabolic diseases by targeting the biology of human aging, on dosing the first participant in QUELL-CV, a Phase 2 proof-of-concept clinical trial of BGE-102, a potent, structurally novel, orally available, brain-penetrant small molecule NLRP3 inhibitor.
BGE-102 was developed from a hit compound identified via HitGen’s industry-leading DEL (DNA-Encoded Library) technology platform. It is being developed as a once-daily oral therapy, with cardiovascular risk reduction as the lead indication. The Phase 1 results reported by BioAge have positioned BGE-102 as a potential best-in-class NLRP3 inhibitor, with profound hsCRP reductions on a well-tolerated, once-daily oral dose. QUELL-CV is a randomized, double-blind, placebo-controlled, dose-ranging Phase 2 proof-of-concept trial evaluating BGE-102 in participants at elevated cardiovascular risk; the trial is designed to inform optimal dose selection in Phase 3 and BGE-102’s path forward in cardiovascular disease. Topline data are anticipated in the second half of 2026.
The collaboration between HitGen and BioAge has previously resulted in the successful identification of promising hit molecules announced in April 2021, a joint publication in Bioorganic & Medicinal Chemistry Letters in February 2024 entitled "The discovery of novel and potent indazole NLRP3 inhibitors enabled by DNA-encoded library screening", and joint patent filings covering the structurally novel compounds discovered through the DEL screening process. The two companies continue to collaborate on additional drug discovery programs for other novel targets using HitGen’s DEL platform.
"We are very pleased to see BGE‑102 reach the Phase 2 milestone," said Dr. Jin Li, Chairman of the Board and Chief Executive Officer of HitGen Inc. "This achievement not only underscores the power of our DEL platform in generating novel small‑molecule leads against challenging targets, but also highlights the strength of our collaborative model with BioAge. We are excited to continue our partnership and watch this promising candidate progress further."
"Reaching Phase 2 is an important milestone for BGE-102 and for our collaboration with HitGen," said Kristen Fortney, Ph.D., CEO and co-founder of BioAge. "HitGen’s DEL platform helped us identify structurally novel NLRP3 inhibitor hits. Our medicinal chemistry team advanced those hits into BGE-102, an oral, brain-penetrant molecule that engages a novel NLRP3 binding site and that produced profound hsCRP reductions in our Phase 1 trial. We look forward to continuing our collaboration with HitGen to identify novel starting points against additional targets across our pipeline."
Leveraging its internationally recognized DEL technology platform and a suite of complementary drug discovery platforms, HitGen has established a distinctive discovery engine that delivers both therapeutics molecules and novel tool molecules to the global pharmaceutical industry. Its DEL platform includes over 1.2 trillion small molecules, and the efficiency of the screening process has made it possible for HitGen to enable drug discovery projects for many organizations worldwide. As of the end of 2025, the company has partnered with over 600 clients globally and contributed to thousands of their innovative drug development projects.
About HitGen Inc.
HitGen Inc. (SSE: 688222.SH) is dedicated to building a world-class innovative biopharmaceutical enterprise. Driven by the mission to advance human health and quality of life, it provides innovative therapeutic solutions to address unmet medical needs. Centered on its internationally leading DEL (DNA-encoded Library) technology, the Company has expanded into Fragment-Based Drug Discovery and Structure-Based Drug Design and a suite of complementary platforms based on Oligonucleotide-based Therapeutics, Targeted Proximity Drugs, and Cyclic Peptidomimetics, and has developed HAILO, a proprietary "DEL+AI+Automation" molecular optimization platform, thereby establishing a distinctive novel molecule discovery engine that delivers both therapeutics molecules and tool molecules to the global pharmaceutical industry. Headquartered in Chengdu, China, HitGen maintains subsidiaries in Cambridge, UK, and Houston, USA, with its operational network spanning the globe. Through diversified and flexible business models including technical services, project out-licensing and product sales, the Company has forged extensive collaborations with a broad range of pharmaceutical and biotechnology companies, chemical firms, foundations, and research institutions. As of the end of 2025, it has empowered over 600 clients globally and contributed to thousands of their innovative drug development projects. HitGen also advances multiple internal programmes at various clinical and preclinical stages. For more information, please visit www.hitgen.com.
About BioAge Labs, Inc.
BioAge is a clinical-stage biopharmaceutical company developing therapeutic product candidates for cardiometabolic diseases by targeting the biology of human aging. The Company’s lead product candidate, BGE-102, is a potent, structurally novel, orally available, brain-penetrant small-molecule NLRP3 inhibitor being developed for cardiovascular risk and retinal diseases including diabetic macular edema. BGE-102 has completed a Phase 1 SAD/MAD trial demonstrating a well-tolerated profile and potential best-in-class reductions in hsCRP and other inflammatory biomarkers in participants with obesity and elevated inflammation. Phase 2 cardiovascular risk proof-of-concept data are anticipated by end of year 2026, and Phase 1b/2a diabetic macular edema proof-of-concept data are anticipated in mid-2027. The Company is also developing long-acting injectable and oral small molecule APJ agonists for obesity. BioAge’s additional preclinical programs, which leverage insights from the Company’s proprietary discovery platform built on human longevity data, address key pathways involved in metabolic aging.
